TRUEtrack TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM NOT FOR RETAIL SALERecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00021292001971), received between Dec 13, 2016 and Sep 21, 2021 — classified as 28 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 reports).

3 other recalls cover devices cleared under the same FDA submission (K032657); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021No Apparent Adverse Event; No Apparent Adverse Event

  MOTHER CALLING ON BEHALF OF CUSTOMER FOR ASSISTANCE WITH METER AND STRIPS. ADVISED CALLER THAT THE TEST STRIPS ARE EXPIRED, AND TO DISCARD AND PURCHASE NEW TRACK TEST STRIPS. CUSTOMER DID NOT ALLEGE A PRODUCT DEFECT. CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION WITH USE OF PRODUCT WAS NOT REPORTED. THE TEST STRIPS ARE EXPIRED: 09/13/2017. CUSTOMER TEST STRIPS HAVE BEEN AFFECTED BY THE RECALL.

  Patient problems: Insufficient Information

  MAUDE report 12506138 ↗
• MalfunctionOct 5, 2020Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR DEFECTIVE LCD DISPLAY/PARTIAL CHARACTERS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS, AND NO MEDICAL ATTENTION WAS REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2022, AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10626780 ↗
• MalfunctionOct 29, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS85-100MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/31/2020 AND OPEN VIAL DATE IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016779 ↗
• MalfunctionOct 25, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 320, 381, 456, 227 AND 175MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/13/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET; CUSTOMER WAS NOT CONCERNED WITH RESULTS OF 456 AND 227 MG/DL BEING ERRATIC): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005720 ↗
• MalfunctionOct 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 394 AND 540 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 250 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2018 SHE HAD AWOKEN FROM HER NAP FEELING ILL; SHE HAD FELT WEAK, LIGHT HEATED AND HAD HEART PALPITATIONS. CUSTOMER STATED SHE HAD PERFORMED A BLOOD TEST AND HAD OBTAINED A RESULT OF 540 MG/DL FASTING. CUSTOMER HAD CALLED 911 AND WHILE IN ROUTE, CUSTOMER STATED THE PARAMEDICS HAD INSTRUCTED HER TO ADMINISTER ASPIRIN, WHICH SHE DID. CUSTOMER STATED THAT THE PARAMEDICS ARRIVED AT HER HOUSE 15 MINUTES LATER AND HAD PERFORMED A BLOOD TEST USING THEIR METER AND HAD OBTAINED A RESULT OF 380 MG/DL. THE PARAMEDICS HAD THEN TRANSPORTED THE CUSTOMER TO THE ER. UPON ARRIVAL, A BLOOD TEST WAS PERFORMED USING THE HOSPITAL'S METER AND CUSTOMER STATED THE RESULT WAS IN THE 300'S (CUSTOMER DID NOT REMEMBER THE EXACT NUMBER). CUSTOMER ALSO STATED THAT AN A1C TEST HAD ALSO BEEN PERFORMED AND THE RESULT WAS 10.7. THE DIAGNOSIS WAS HYPERGLYCEMIA AND 20 UNITS O

  Patient problems: Hyperglycemia; Palpitations; Weakness

  MAUDE report 7922717 ↗
• MalfunctionSep 24, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SWEATY AND LETHARGIC. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/15 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER NEEDED ASSISTANCE WITH THE METER REGARDING THE E3 ERROR. THE ERROR APPEARED AS SOON AS THE TEST STRIP WAS INSERTED IN THE METER. STRIPS ARE EXPIRED. CUSTOMER STATES THAT SHE WENT TO THE PHARMACY TO GET STRIPS, BUT THEY ARE NOT AVAILABLE. CUSTOMER STATES THAT SHE IS SWEATY AND LETHARGIC. CUSTOMER DECLINED A REPLACEMENT METER AND ONLY WANTS TO BE SENT TEST STRIPS.

  Patient problems: Lethargy; Sweating

  MAUDE report 7902057 ↗
• MalfunctionFeb 12, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. CAREGIVER STATED THAT HI WAS OBTAINED ON TWO DIFFERENT METERS. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL, CAREGIVER STATED THE CUSTOMER WAS SLEEPING A LOT AND WAS VERY TIRED. CAREGIVER STATED THAT SHE WAS GOING TO CALL 9-1-1. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2018 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; PARAMEDICS READ HI ON (B)(6) 2018. CUSTOMER WAS HOSPITALIZED ON (B)(6) 2018 AND DISCHARGED ON (B)(6) 2018. CUSTOMER WAS RE-ADMITTED ON (B)(6) 2018 AND DISCHARGED AGAIN ON (B)(6) 2018 FOR HYPERGLYCEMIA. CUSTOMER WAS TREATED WITH INSULIN. WAS GIVEN NEW MEDICATIONS, INSULIN AND A NEW DIET. CUSTOMER IS FEELING BETTER AND IS NO LONGER EXPERIENCING SYMPTOMS RELATED TO DIABETES.

  Patient problems: Fatigue

  MAUDE report 7265347 ↗
• MalfunctionJan 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI, 523, 587 AND 586 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 150 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF INCREASED URINATION AND INCREASED THIRST; CUSTOMER DID NOT NEED MEDICAL ATTENTION AT TIME OF CALL. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. CUSTOMER'S TEST STRIPS ARE EXPIRED - THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/19/2014 AND CUSTOMER DID NOT KNOW THE OPEN VIAL DATE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH THE RESULTS OF HI, 523, 587 AND 586 MG/DL IN THE METERS MEMORY.

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7209670 ↗
• MalfunctionDec 21, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 221, 186, 211 AND 174 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 159 MG/DL AND 151 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/22/2019 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH THE RESULTS OF 221, 186, 211 AND 174 MG/DL IN THE METERS MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139775 ↗
• MalfunctionDec 15, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 250MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 188 AND 167 MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/15/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1 :250MG/DL DATE: (B)(6) 2017 TIME:12:10PM FASTING. RESULT 2 :171MG/DL DATE: (B)(6) 2017 TIME:12:03PM FASTING. RESULT 3 :199MG/DL DATE: (B)(6) 2017 TIME:12:20PM FASTING. RESULT 4 :184MG/DL DATE: (B)(6) 2017 TIME:12:21PM FASTING. CUSTOMER IS CALLING BECAUSE HE STATES HIS METER IS READING INACCURATELY. CUSTOMER JUST GOT THE METER TODAY AND WHEN HE TOOK HIS FIRST BLOOD TEST, IT READ HIGHER THAN HIS NORMAL GLUCOSE RANGE OF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7120872 ↗
• MalfunctionNov 8, 2017Low Test Results; Low Test Results

  CUSTOMER USED THE METER ON HIS FRIEND AND THE METER READ LO. HIS FRIEND IS CURRENTLY IN THE HOSPITAL ON (B)(6) 2017 DUE TO A HYPOGLYCEMIC EVENT. FRIEND (DAVID SMITH) STATES MONDAY NIGHT THE CUSTOMER USED HIS NORMAL AMOUNT OF INSULIN BUT CALLER STATES THE CUSTOMER'S SUGAR WASN'T AS HIGH AS IT HAS BEEN AND THEREFORE IT ATTRIBUTED TO THE LOW THAT WAS EXPERIENCED BY THE CUSTOMER TUESDAY MORNING. CALLER STATES THE CUSTOMER IS NOT EDUCATED ON HIS DIABETES AND BELIEVES HE SHOULD BE ON A SLIDING SCALE. CALLER STATES THE CUSTOMERS SUGAR PLUMMETED TUESDAY MORNING. CALLER STATES THE CUSTOMER GOT OUT OF HIS BUNK BED AND FELL ON THE BOTTOM BUNK AND LANDED THERE. CALLER STATES THEY FOUND THE CUSTOMER LAYING ON THE BED OF THE BOTTOM BUNK. THEY CALLED THE PARAMEDICS AND THEY ARRIVED 15 MINUTES LATER. CUSTOMER WAS NON-MOBILE, LETHARGIC, AND INCOHERENT AT THE TIME OF THE INCIDENT. CALLER ALSO STATES HE FOUND HIM SWEATY. CALLER STATES THE CUSTOMER WAS PUT ON AN IV TO HYDRATE HIM. HE STATES THE CUSTOMER WAS ALSO GIVEN A LIQUID GLUCOSE TABLET AND THE CUSTOMER WAS ADMITTED TO THE HOSPITAL (B)(6) 2017 AT 8:15AM. THE FRIEND'S EXPECTED FASTING BLOOD GLUCOSE RANGE IS UNDISCLOSED. THE PRODUCT IS STORED BY CU

  Patient problems: Lethargy; Sweating

  MAUDE report 7009789 ↗
• MalfunctionSep 20, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 195, 157 AND 277 MG/DL. DURING A ROUTINE DOCTOR'S VISIT, THE CUSTOMER SHARED RESULTS WITH THE DOCTOR AND DOCTOR STATED RESULTS WERE TOO HIGH BASED ON CUSTOMER'S A1C. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 233 MG/DL AND 216 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE AT TIME OF CALL IS A WEEK; CUSTOMER'S TEST STRIPS ARE PART OF RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880036 ↗
• MalfunctionAug 30, 2017High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 250 TO 300MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FATIGUE, EXCESS URINATION, THIRST AND BLURRY VISION. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/23/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER IS FEELING LIKE HER SUGAR IS VERY HIGH, SHE HAD A PANIC ATTACK FROM BEING IN THE HEAT AND STATES THAT MAY RAISE HER SUGAR, ALSO THAT SHE IS ON HER MENSTRUAL CYCLE AND BEING ON HER CYCLE MAY RAISE HER SUGAR UP AN EXTRA 100MG/DL RESULTING IN AN AVERAGE OF 250-300MG/DL. INSTRUCTED CUSTOMER TO SEEK MEDICAL ATTENTION ASAP. CUSTOMER STATES SHE WILL CALL FOR HELP. INFORMED CUSTOMER I WILL CALL HER IN 30 MIN. ON 8/21/2017 A FOLLOW UP CALL BACK WAS MADE: UNABLE TO REACH CUSTOMER- LEFT VOICEMAIL.

  Patient problems: Blurred Vision; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 6831551 ↗
• MalfunctionAug 22, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THEY JUST STARTED TO USE THE TRUETRACK METER (B)(6) 2017. THE CUSTOMER IS CONCERNED WITH ALL TESTS RESULTS FROM THE METER MEMORY. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 110 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON 08/01/2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/14/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 148MG/DL (B)(6) 2017 09:00 AM FASTING: YES, 260MG/DL (B)(6) 2017 10:25 PM FASTING: YES, 325MG/DL (B)(6) 2017 10:00 PM FASTING: YES. CUSTOMER STATES THAT THEY JUST STARTED TO USE THE TRUETRACK METER YESTERDAY AND IS GIVING ABOUT 100MG/DL HIGHER WHEN COMPARE TO THE TRUE RESULTS METER THAT HE WAS USING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6810203 ↗
• MalfunctionJul 18, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 87, 90 AND 107 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 200 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 87MG/DL (B)(6) 2017 08:00 AM FASTING:YES; 113MG/DL (B)(6) 2017 08:00 AM FASTING:YES; 90MG/DL (B)(6) 2017 08:00 AM FASTING:YES; 110MG/DL (B)(6) 2017 08:00 AM FASTING:YES; 107MG/DL (B)(6) 2017 08:00 AM FASTING:YES. MEMORY CONCERNS: 87, 90, 107, 110, 113MG/DL. CUSTOMER IS CONCERNED WITH LOW READINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723039 ↗
• MalfunctionJul 12, 2017Low Test Results; Low Test Results

  CUSTOMER CALLING CONCERNED HER METER IS DISPLAYING RESULTS THAT SHE CONSIDERS ARE LOW FOR HER. CUSTOMER METER READING RESULTS OF 87 MG/DL THIS MORNING FASTING. CUSTOMER EXPECTED BLOOD GLUCOSE RANGES OF 96 MG/DL-140 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED BECAUSE OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 9/30/2017 AND OPEN VIAL DATE IS (B)(6) 2015. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 104MG/DL (B)(6) 2015 09:00:00 AM FASTING:YES; 90MG/DL (B)(6) 2015 03:00:00 PM FASTING:NO; 165MG/DL (B)(6) 2015 04:15:00 PM FASTING:NO; 111MG/DL (B)(6) 2015 05:30:00 PM FASTING:NO; 94MG/DL (B)(6) 2015 06:15:00 PM FASTING:NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6706707 ↗
• MalfunctionJul 10, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. STRIP EXPIRATION DATE IS 10/15/2017 AND STRIP OPEN DATE IS (B)(6) 2016. REVIEWED METER MEMORY: 82MG/DL (B)(6) 2016 08:20:00 AM FASTING: NO; 99MG/DL (B)(6) 2016 11:40:00 PM FASTING: NO; 99MG/DL (B)(6) 2016 12:12:00 AM FASTING: NO; 163MG/DL (B)(6) 2016 03:18:00 PM FASTING: NO; 96MG/DL (B)(6) 2016 08:48:00 AM FASTING: NO. MEMORY CONCERNS: CONCERN WITH 82 ON (B)(6) 2016 08:20:00 AM. CUSTOMER CALLED CONCERNED THAT HIS METER WAS READING HIS BLOOD SUGAR OF 82 MG/DL-15 MINUTES AFTER EATING. I CONFIRMED THAT HE WAS FEELING FINE (ASYMPTOMATIC), THERE WAS NO NEED ANY MEDICAL INTERVENTION AT THE TIME OF THE CALL OR THE RESULT IN QUESTION. HE HADN'T MADE ANY CHANGES TO HIS DIET OR MEDICATION (METFORMIN). HIS EXPECTED BLOOD SUGAR LEVELS SHOULD BE BETWEEN 115-120 (FASTING). I ALSO VERIFIED THAT HE HAD PROPERLY STORING HIS SUPPLIES ON THE LIVING ROOM TABLE AT ROOM TEMPERATURE. I HAD HIM RUN A BACK TO BACK TEST, RESULTS READ 113 AND 104 MG/DL (ABOUT A HALF HOUR AFTER EATING). HE STATED HE NORMALLY TEST AFTER EATING AS RECOMMENDED BY HIS DOCTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6698798 ↗
• MalfunctionJul 10, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. CUSTOMER REPORTED NO SYMPTOMS, AND DOES NOT NEED MEDICAL ATTENTION. STRIP EXPIRATION DATE IS 11/28/2017 AND STRIP OPEN DATE IS WEEK OF (B)(6) 2015. REVIEWED METER MEMORY: (B)(6). CUSTOMER IS CALLING WITH A COMPLAINT HIS TRUE TRACK METER WAS GIVING HIM RESULTS LOWER THAN THAT OF HIS EXPECTED FASTING RANGE OF 110-120 MG/DL. CUSTOMER WAS CONCERNED WHEN HE OBTAINED A RESULT 85 MG/DL ON (B)(6) 2015 AT 10:02 AM. CUSTOMER ALSO WAS CONCERNED AS HIS HGBA1C WAS 7.6 AND HIS LAB WORK GAVE A BLOOD GLUCOSE LEVEL 132 MG/DL AND WHEN HE TESTED 1 HOUR EARLIER THE METER GAVE HIM A RESULT OF 106 MG/DL. CUSTOMER STATED HE HAD NO SYMPTOMS OF HYPO/HYPERGLYCEMIA NOTED AT THIS TIME. CUSTOMER DENIES ANY CHANGES IN DIET, EXERCISE, MEDICATION, OR HEALTH STATUS. THE METER AND STRIPS WERE NOT PROPERLY STORED AS THEY ARE KEPT IN THE KITCHEN OF THE HOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6698768 ↗
• MalfunctionJun 26, 2017Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR "---"ACCOMPANIED BY SYMPTOMS. (B)(6) IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING WEAK AND SWEATY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/18/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Sweating; Weakness

  MAUDE report 6666920 ↗
• MalfunctionJun 6, 2017Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR BATTERY ISSUE \ DEAD METER. THE CUSTOMER STATED THAT THE METER COMES ON BUT SHUTS OFF QUICKLY. DURING THE CALL ON (B)(6) 2017 IT WAS VERIFIED THAT THE METER CAME ON AND SHUT OFF AFTER INSERTING A TEST STRIP AND BY MANUALLY PRESSING THE "S" BUTTON. THE STRIP WAS INSERTED IN THE METER CORRECTLY AND THE RIGHT BRAND OF STRIPS WAS BEING USED. THE BATTERY WAS IN THE METER CORRECTLY. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017 THE CUSTOMER STATED SHE HAD A HEADACHE AND THAT IT COULD BE FROM DIABETES. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Headache

  MAUDE report 6615491 ↗
• MalfunctionMay 25, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. JACKIE/DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 317MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 117 AND 132MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CAL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 317 AND 302MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/24/2018 AND OPEN VIAL DATE IS APPROXIMATELY TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). DAUGHTER COMPARED RESULTS TO HOSPITAL METER THAT READ 189MG/DL FASTING AND TRUE METRIX METER READ 268MG/DL FASTING. CUSTOMER IS CURRENTLY IN THE HOSPITAL FOR A BLEEDING ULCER. DAUGHTER (JACKIE) STATES CUSTOMER'S GLUCOSE WAS 131 WHEN ADMITTED TO THE HOSPITAL. DAUGHTER STATES ADMISSION HAS NOTHING TO DO WITH CUSTOMER'S DIABETES OR USE OF THE METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6590849 ↗
• MalfunctionMay 24, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 115MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 225 AND 232MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/21/2018 AND OPEN VIAL DATE IS APPROXIMATELY TWO MONTHS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER CALLED CONCERNING HIGH RESULTS. CUSTOMER SAYS THAT ALL OF HIS RESULTS ARE HIGHER THAN EXPECTED RANGE. ALSO, CUSTOMER STATES THAT RECENTLY, CUSTOMER NOT SURE EXACTLY OF WHICH DATE, HE WENT INTO THE EMERGENCY ROOM FOR A REASON NOT RELATED TO DIABETES. CUSTOMER SAID THAT HE BROUGHT HIS METER ALONG WITH HIM AND HAD A NURSE CHECK HIS GLUCOSE LEVELS WITH HOSPITAL METER AND THEN WITH TRUE TRACK ME

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6589167 ↗
• MalfunctionMay 24, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 218MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 138 AND 140MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER CALLED IN REPORTING HIGH RESULTS. CUSTOMER STATES HE WAS CONCERNED WITH RESULTS ON HIS METER AND WENT TO HIS DOCTOR TO COMPARE WITH HIS LAB RESULTS AND STATES HIS LAB CAME TO 98MG/DL BUT HIS METER WAS TOO HIGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6587204 ↗
• MalfunctionMay 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER CALLED FOR ASSISTANCE IN RUNNING A BLOOD TEST. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER STATED THAT SHE WAS FEELING DIZZY AND TIRED. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 240 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2017 AND OPEN VIAL DATE WAS UNDISCLOSED. CUSTOMER'S TEST STRIPS ARE PART OF RECALL. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS PROPERLY TRAINED ON HOW TO RUN A BLOOD GLUCOSE TEST.

  Patient problems: Dizziness; Fatigue

  MAUDE report 6581574 ↗
• MalfunctionApr 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 175 AND 174MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/22/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). THE CUSTOMER IS CALLING IN REGARDS TO GETTING HIGH RESULTS WHEN SHE TESTS ON THE METER. THE CUSTOMER IS NOT HAVING ANY SYMPTOMS OF HIGH BLOOD SUGAR AT THIS TIME. SHE TAKES HER BLOOD TEST FASTING. SHE HAS NOT HAD ANY CHANGES IN DIET OR EXERCISE. CUSTOMER STATES HER BLOOD SUGAR IN THE PAST FEW MONTHS HAVE BEEN GOING UP AND DOWN AND WHEN SHE USES THE TRUE TRACK METER ON (B)(6) 2017 HER BLOOD SUGAR IS HIGH. THE STRIPS SHE WAS USING ON THE 6TH ((B

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461094 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032657. One submission often covers many models, so check the product and lot details in each record.

• Z-2881-2016 · Jun 28, 2016 · Open, Classified
  TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50
• Z-0910-2014 · Oct 2, 2013 · Terminated
  MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 333
• Z-1140-2013 · Feb 25, 2013 · Terminated
  Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole